MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Device Alarm System (1012); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

D5.Operator of device is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device was leaking by the "straining tube and keep alarming".No patient or clinical injury was reported.

Manufacturer Narrative

Device evaluation: one device was received.Per visual inspection, the enclosure was cracked around the quick connect and the device was leaking from the crack, quick connect was corroded.Per functional testing, the device is leaking from the quick connect where the crack was but could not confirm the customer complaint that the alarm kept alarming.The root cause for the leak was the cracked enclosure.It was unknown what caused the condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced enclosure, quick connect, reservoir gasket, o-rings.Replaced membrane switch and hl-30 label.Performed preventative maintenance (pm) and calibration.The device passed all functional and delivery tests after repair.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18607637
• MDR Text Key: 334177849
• Report Number: 2183161-2024-00115
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1